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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01838356
Other study ID # 1202009664
Secondary ID
Status Completed
Phase N/A
First received April 15, 2013
Last updated January 12, 2018
Start date September 2012

Study information

Verified date January 2018
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of the study is to examine if blood flow in the brain before coronary artery bypass graft surgery has an effect on depression after surgery.

The main hypothesis of the study states that pre-surgical blood flow in the brain will be an independent risk factor for depression after surgery after adjusting for other risk factors such as gender, pre-CABG depression, social support, medical comorbidity burden, socioeconomic status, and neuroticism.


Recruitment information / eligibility

Status Completed
Enrollment 169
Est. completion date
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria:

- Age: 40 years or older

- Will be having CABG surgery at the Yale New Haven Hospital

- Be able to provide informed consent

- Have a household telephone

- A fluent English speaker, and possessing no communication barrier

- Be able to come to the study site or to have the study team come to his/her home.

- Has a family member or partner/ friend who could provide collateral information

Exclusion Criteria:

- Has had previous CABG surgery

- History of dementia diagnosis or cognitive impairment (CDR >/= 1)

- Auditory or visual impairment that would interfere with study procedures

- Active alcohol or substance abuse problem based CAGE-AID (endorsing two or more items)

- History of Bipolar Disorder, Schizophrenia, Schizoaffective Disorder, or any Psychotic Disorder by medical history or self-report.

- Presence of non-cardiovascular conditions likely to be fatal within 1 year

Study Design


Locations

Country Name City State
United States The Johns Hopkins University Baltimore Maryland
United States Yale University School of Medicine New Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pre-surgical intracranial atherosclerosis as measured by transcranial doppler ultrasound relative to depressive symptoms post-surgically as measured by DISH. 12 months
Secondary Examine neurocognitive function relative to post-CABG depression through a series of neurocognitive tests. Neurocognitive tests are aimed at evaluating memory, processing speed, and global cognition. 12 months
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